Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease

(Subjects on drug were more likely to have severe pain crises requiring hospitalization.)

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00492531

First Posted: June 27, 2007

Last Update Posted: January 6, 2016

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Subjects with Sickle cell hemoglobinopathy were recruited from 10 centers(9 in United States and 1 in United Kingdom)

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Sildenafil

Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).

Placebo

Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Sildenafil

Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).

Placebo

Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).

Total

Total of all reporting groups

Baseline Measures

Sildenafil

Placebo

Total

Overall Participants Analyzed [Units: Participants]

37

37

74

Age [Units: Years]Mean (Standard Deviation)

47 (13)

44 (14)

45 (13)

Gender [Units: Participants]

Female

23

23

46

Male

14

14

28

Ethnicity (NIH/OMB) [Units: Participants]

Hispanic or Latino

0

0

0

Not Hispanic or Latino

32

37

69

Unknown or Not Reported

5

0

5

Race (NIH/OMB) [Units: Participants]

American Indian or Alaska Native

0

0

0

Asian

0

0

0

Native Hawaiian or Other Pacific Islander

0

0

0

Black or African American

36

37

73

White

0

0

0

More than one race

0

0

0

Unknown or Not Reported

1

0

1

6 minute walk [1] [Units: Meters]Mean (Standard Deviation)

381 (75)

386 (75)

383 (75)

[1]

The distance walked in six minute was used to assess the exercise capacity of the patient at baseline.

Treatment group differences in AEs and SAEs were evaluated via Cochran-Mantel-Haenszel chi-square tests, controlling for TRV stratum. The study was stopped early due to the higher percentage of subjects experiencing an SAE in the sildenafil arm as compared to the placebo arm.

Reporting Groups

Description

Sildenafil

Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).

Placebo

Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).